Safety shield for medical needles

ABSTRACT

A safety shield apparatus is disclosed which includes a needle having a distal portion defining a longitudinal axis which is angularly displaced relative to a longitudinal axis defined by a proximal portion of the needle. A shield is mounted with the needle and extensible, via a tubular needle guide movable along the needle, between a retracted position and an extended position. The apparatus may include a needle hub configured to support the proximal portion of the needle. The needle hub can include an appendage which may have at least one opening to facilitate manipulation thereof. A distal end of the shield can be attached to a planar contact surface. The shield may also include a latch engageable with the needle.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application is a continuation of Utility patentapplication Ser. No. 10/016,276, filed in the U.S. Patent and TrademarkOffice (USPTO) on Dec. 6, 2001 by Barrus et al., which is acontinuation-in-part of U.S. Utility patent application Ser. No.09/892,593, filed in the USPTO on Jun. 27, 2001 by Ferguson et al., andclaims priority to U.S. Provisional Application Serial No. 60/254,506filed in the USPTO on Dec. 8, 2000 by Thome et al., and U.S. ProvisionalApplication Serial No. 60/296,968 filed in the USPTO on Jun. 8, 2001 byBarrus et al., the entire contents of each of these applications beinghereby incorporated by reference herein.

BACKGROUND

[0002] 1. Technical Field

[0003] The present disclosure generally relates to safety shields formedical needles, and more particularly, to safety shields that areextensible to prevent hazardous exposure to a port access medicalneedle.

[0004] 2. Description of the Related Art

[0005] Cross-contamination and infection from potentially fatal diseasestransmitted by inadvertent needle sticks have resulted in thedevelopment of a wide variety of safety medical needle devices used inthe areas of I.V. therapy, phlebotomy, syringes and specialty medicalneedle devices. These diseases include the HIV virus, several strains ofhepatitis and other blood and body fluid borne diseases.

[0006] Vascular access ports can be surgically implanted to facilitateremoval of bodily fluids, such as, for example, blood for testing.Access ports also provide a temporary site for repeated fluid removal,infusion of intravenous fluids or medication infusion. An access port istypically positioned internally on a body surface of a patient, such as,for example, in the chest or abdomen, to facilitate disposition of acatheter into a blood vessel.

[0007] Typically, port access medical needles, such as a Huber needle,are used with the access ports which are implanted for direct vascularcommunication. Huber needles typically include an angled cannula shafthaving a sharpened tip portion oriented at approximately 90 degreesrelative to an attachment portion that connects to a fluid source and/ora fluid receptacle. The angular bend in the cannula shaft allows theattachment portion to be secured to the patient while the access port isemployed.

[0008] Access ports typically include a septum positioned under thesurface of the patient's skin, and adapted to receive a Huber needlepuncture at a percutaneous insertion site. The septum is conventionallyfabricated from a thick elastomeric membrane which facilitates needlepenetration and provides an inner chamber for the infusion of medicationor removal of bodily fluids.

[0009] Huber needles may be particularly difficult to remove from aneedle access port which can result in hazardous exposure of the needleto a patient and a clinician. This is due, at least in part, to the factthat access port septums exhibit forces associated with needle entry andremoval, which are much greater than forces normally associated withother medical needle insertion and removal (e.g., with syringes orphlebotomy needles). “Rebound” injuries are typically encountered withHuber needles because of the force required to overcome resistance ofthe septum of the access port. Further, other factors can contribute tothe septum's resistance, such as, for example, the needle tip may becomebarbed, skin may adhere to the needle shaft, etc.

[0010] Attempts at overcoming the above retention and resistive forcesmay result in a reflexive motion (e.g., a jerk) by the clinicianremoving the needle at the time of extraction which can contribute tothe “rebound” injuries. The reflexive motion may be poorly controlled,oscillatory and, therefore, result in an inadvertent needle stick to thepatient and clinician, for example, to a hand which is stabilizing animplanted port. Further, difficulty in removal can force a clinician tomake a perpendicular pull, which is transverse to a plane orthogonal tothe direction of needle insertion. This can result in injury to thepatient and the clinician.

[0011] A number of Huber needle safety devices are known. For example,one particular device involves a shield separate from the needle forshielding the needle. These types of devices disadvantageously requiremanipulation and operation of separate devices for shielding the needle.These devices are also bulky and cumbersome which can affect accuracy ofplacement during use.

[0012] Another known attempt at reducing hazards associated with angledneedles is a safety device that includes a collapsible pair of wingsengaged by the fingers of a clinician to shield the needle. A drawbackof devices of this type is that a narrow surface area presses against apatient's skin during withdrawal, which can cause significant pain anddiscomfort.

[0013] The prior art devices may not adequately and reliably shield portaccess needles to prevent hazardous exposure. A continuing need existsto overcome the disadvantages and drawbacks of the prior art and providea more adequate and reliable safety apparatus for angled needle deviceswhich sheaths a needle upon removal from an insertion site. Such asafety apparatus may be actuated without applying substantial transverseforces to the needle during removal, while complementing the currentuser technique.

[0014] Therefore, it would be desirable to have a safety apparatus forport access needle devices that sheaths a needle upon removal from aninsertion site. It would be highly desirable if the safety apparatus wasactuated without applying substantial transverse forces to the needleduring removal.

SUMMARY

[0015] Accordingly, a safety apparatus for port access needle devicesthat adequately and reliably sheaths a needle upon removal from aninsertion site is disclosed. The safety apparatus prevents hazardousexposure to the needle while providing dependable performance andincreased safety to a patient and clinician during a medical procedure.The safety apparatus may be actuated without applying substantialtransverse forces to the needle during removal. One of the advantages ofthe present disclosure is a safety apparatus through which extractingforces are directed along a longitudinal axis of the needle. Anotheradvantage of the present disclosure is port access medical needle whichforms a compact low silhouette about an insertion site while the needleis inserted. Yet another advantage of the present disclosure is a safetyapparatus which is efficiently and inexpensively manufactured andassembled. Desirably, the safety apparatus is assembled from twoinjection molded parts.

[0016] Objects and advantages of the present disclosure are set forth inpart herein and in part will be obvious therefrom, or may be learned bypractice of the present disclosure, which is realized and attained bymeans of the instrumentalities and combinations pointed out in theappended claims. The apparatus and methods of the present disclosureconsist of novel parts, constructions, arrangements, combinations, stepsand improvements herein shown and described.

[0017] The safety apparatus disclosed permits a retracting force to beapplied directly above a needle insertion site and may include anelongated, slender core structure for ease of maneuverability tofacilitate needle entry into difficult to access ports or vessels. Thesafety apparatus can provide shielding of a sharpened tip of a portaccess medical needle, such as, for example, a Huber needle, having asharpened tip at one end and firmly affixed within a needle hub at theother end, during withdrawal from an insertion site. Extraction of theneedle from the insertion site may require forces significantly greaterthan forces associated with extracting other medical needles, such ashypodermic syringes or phlebotomy. Thus, the safety apparatus caninclude a shield assembly having a finger pad for application ofrestraining forces about the insertion site. The finger pad spreadsdigitally applied forces to stabilize the implanted portion of theneedle.

[0018] The shield assembly contains a needle guide through which theneedle travels during needle extraction. A shield is hingedly affixed tothe shield assembly for articulation along the needle during needleextraction. The sharpened tip of the needle is retracted into the shieldassembly, forming a substantially rigid structure of the shield, needleguide, needle hub and needle. A latch may engage the shield assembly tomaintain the rigid structure in a protective configuration about thesharpened tip. Thus, the needle is extracted and shielded withoutapplying substantial transverse forces to the needle.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The objects and features of the present disclosure, which arebelieved to be novel, are set forth with particularity in the appendedclaims. The present disclosure, both as to its organization and mannerof operation, together with further objectives and advantages, may bebest understood by reference to the following description, taken inconnection with the accompanying drawings, wherein:

[0020]FIG. 1 is a side view of one particular embodiment of a safetyshield apparatus in a retracted position, in accordance with theprinciples of the present disclosure;

[0021]FIG. 2 is a front view of the safety shield apparatus shown inFIG. 1;

[0022]FIG. 3 is a side cross-sectional view of the safety shieldapparatus shown in FIG. 1;

[0023]FIG. 4 is a side view of the safety shield apparatus show in FIG.1 in an extended position;

[0024]FIG. 4A is a medial side view, in part cross-section, of thesafety shield apparatus shown in FIG. 4;

[0025]FIG. 5 is a front view of the safety shield apparatus shown inFIG. 1 in an extended position;

[0026]FIG. 6 is a perspective view of the safety shield apparatus shownin FIG. 1 in an extended position;

[0027]FIG. 7 is a side view of a portion of an angled needle of thesafety shield apparatus shown in FIG. 1;

[0028]FIG. 7A is a side view of a portion of a needle hub assembly ofthe safety shield apparatus shown in FIG. 1;

[0029]FIG. 7B is a side view of a portion of a shield of the safetyshield apparatus shown in FIG. 1;

[0030]FIG. 7C is a side view of a portion of a fluid conduit employedwith the safety shield apparatus shown in FIG. 1;

[0031]FIG. 8 is a perspective view of a shield of the safety shieldapparatus shown in FIG. 1;

[0032]FIG. 9 is a perspective view of another embodiment of the safetyshield apparatus;

[0033]FIG. 10 is a side view of the safety shield apparatus shown inFIG. 9;

[0034]FIG. 11 is a perspective view of an alternate embodiment of thesafety shield apparatus, in a retracted position;

[0035]FIG. 12 is a perspective view of the safety shield apparatus shownin FIG. 11, in an extended position;

[0036]FIG. 13 is a perspective view of another alternate embodiment ofthe safety shield apparatus in a retracted position;

[0037]FIG. 14 is a side cross-sectional view of the safety shieldapparatus shown in FIG. 13;

[0038]FIG. 15 is a perspective view of the safety shield apparatus shownin FIG. 13, in an extended position;

[0039]FIG. 16 is a side view of the safety shield apparatus shown inFIG. 15;

[0040]FIG. 17 is a side cross-sectional view of the safety shieldapparatus shown in FIG. 15;

[0041]FIG. 18 is a perspective view of the component parts of the safetyshield apparatus shown in FIG. 13;

[0042]FIG. 19 is a perspective view of another alternate embodiment ofthe safety shield apparatus in a retracted position;

[0043]FIG. 20 is a cross-sectional view of the safety shield apparatusshown in FIG. 19;

[0044]FIG. 21 is a perspective view of the safety shield apparatus shownin FIG. 19 fully extended;

[0045]FIG. 22 is a cross-sectional view of the safety shield apparatusshown in FIG. 21;

[0046]FIG. 23 is a perspective view of the safety shield apparatus shownin FIG. 19 in a retracted position showing an alternate embodiment of alinear bearing with a foam disc;

[0047]FIGS. 24 and 24A are perspective views of the safety shieldapparatus shown in FIG. 23 fully extended and having the foam discseparated;

[0048]FIGS. 25 and 25A are perspective views of the safety shieldapparatus shown in FIG. 19 showing an alternate embodiment,of-a linearbearing and the shield separated from the needle hub and wing assembly;

[0049]FIG. 26 is a cross-sectional view of the safety shield apparatusshown in FIG. 19 showing an embodiment of a needle latch;

[0050]FIG. 27 is a rear view of the safety shield apparatus shown inFIG. 19 showing the needle latch shown in FIG. 26;

[0051]FIG. 28 is a perspective view of the safety shield apparatus shownin FIG. 19 showing an additional lockout feature;

[0052]FIG. 29 is a perspective view of the safety shield apparatus shownin FIG. 19 illustrating an embodiment of a latch for retaining thesafety shield apparatus in a retracted position;

[0053]FIG. 30 is a perspective view of the safety shield apparatus shownin FIG. 19 showing an alternate embodiment of a disc;

[0054]FIG. 31 is an enlarged bottom view of an alternate embodiment of alatch of the safety shield apparatus illustrated in FIG. 19;

[0055]FIG. 32 is a side cross-sectional view of the latch illustrated inFIG. 31.

[0056]FIG. 33 is a perspective view of another alternate embodiment ofthe safety shield apparatus; and

[0057]FIG. 34 is a side cross-sectional view of an alternate embodimentof a needle and hub.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0058] The exemplary embodiments of the safety shield apparatus andmethods of operation disclosed are discussed in terms of medical needlesfor infusion of intravenous fluids, medication infusion or fluidcollection, and more particularly, in terms of port access needleapparatus, employing a needle cannula, that prevent hazardous exposureto the needle cannula, including, for example, inadvertent needle stick.It is contemplated that the safety shield apparatus may also be used forimplanted infusion pumps or other similar implanted devices. It isfurther contemplated that the needle cannula may be shielded during useincluding storage, transport, fluid infusion and/or collection,subsequent thereto, etc. It is envisioned that the present disclosure,however, finds application to a wide variety of cannula needles anddevices for the infusion of preventive medications, medicaments,therapeutics, etc. to a subject. It is also envisioned that the presentdisclosure may be employed for collection of body fluids, including,those employed during procedures relating to phlebotomy, digestive,intestinal, urinary, veterinary, etc.

[0059] In the discussion that follows, the term “proximal” refers to aportion of a structure that is closer to a clinician, and the term“distal” refers to a portion that is further from the clinician. As usedherein, the term “subject” refers to a patient that receives infusionsor has blood and/or fluid collected therefrom using the safety shieldapparatus. According to the present disclosure, the term “clinician”refers to an individual administering an infusion, performing fluidcollection, installing or removing a needle cannula from a safety shieldapparatus and may include support personnel.

[0060] The following discussion includes a description of the safetyshield apparatus, followed by a description of the method of operatingthe safety shield apparatus in accordance with the present disclosure.Reference will now be made in detail to the exemplary embodiments of thedisclosure, which are illustrated in the accompanying figures.

[0061] Turning now to the figures wherein like components are designatedby like reference numerals throughout the several views. Referringinitially to FIGS. 1-8, there is illustrated a safety shield apparatus10, constructed in accordance with the principals of the presentdisclosure, including a needle, such as, for example, medical needle 20having a distal portion defining a longitudinal axis a which isangularly displaced relative to a longitudinal axis b defined by aproximal portion of medical needle 20. A shield, such as, for example,shield assembly 40 is mounted with medical needle 20 and extensible, viaa needle guide 150 movably guiding medical needle 20, between aretracted position (FIG. 1) and an extended position (FIG. 4). It iscontemplated that needle guide 150 may be tubular. Safety shieldapparatus 10 is advantageously configured to prevent hazardous exposureto a needle cannula by providing an adequate and reliable safety shieldapparatus for port access needle devices which sheaths a needle uponremoval from an insertion site, as will be discussed below.

[0062] Shield assembly 40 includes an elongated part 140, discussedbelow, and has a proximal end mounted with the proximal portion ofmedical needle 20 and a distal end mounted with a planar contactsurface, such as, for example, stabilizer part 130, discussed below.Shield assembly 40 is extensible between the retracted position and theextended position via fixed positioning of stabilizer part 130 relativeto movement of shield assembly 40. Thus, another advantage of thepresent disclosure is that safety shield apparatus 10 is actuatedwithout applying substantial transverse forces to medical needle 20during removal, resulting in a higher degree of safety to the clinicianand subject. Further, this configuration of safety shield apparatus 10advantageously provides an automatic sheathing of medical needle 20 asshield assembly 40 is manipulated to the extended position, as will bediscussed.

[0063] Safety shield apparatus 10 is contemplated for use in the fieldof medical fluid infusion and/or collection. More particularly, safetyshield apparatus 10 is envisioned to be a disposable port access needledevice employing, among other things, safety features having shieldingcapabilities to prevent inadvertent sticking or punctures of cliniciansand subjects, as well as uniform and dependable movement of sheathassembly 40 during a procedure and a locking mechanism for reliable use.The above advantages, among others, realized from the present disclosureare attained through the disclosed safety shield apparatus 10, which isextensible to a protective configuration, as discussed hereinbelow.These features of the present disclosure advantageously facilitate asafe infusion and/or collection of fluids and prevent inadvertent needlestick of a clinician and subject.

[0064] The component parts of safety shield apparatus 10 may befabricated from a material suitable for medical applications, such as,for example, polymerics or metals, such as stainless steel, depending onthe particular medical application and/or preference of a clinician.Semi-rigid and rigid polymerics are contemplated for fabrication, aswell as resilient materials, such as molded medical grade polypropylene.However, one skilled in the art will realize that other materials andfabrication methods suitable for assembly and manufacture, in accordancewith the present disclosure, also would be appropriate. Safety shieldapparatus 10 may be integrally assembled of its constituent parts.Alternatively, portions of safety shield apparatus 10 can bemonolithically formed and assembled therewith.

[0065] Referring to FIG. 1, safety shield apparatus 10 is employed witha Huber type needle, such as, medical needle 20. Safety shield apparatus10 includes a medical needle 20, a needle hub assembly 30, a shieldassembly 40 and a section of medical tubing 50.

[0066] In safety shield apparatus 10, medical needle 20 is formed froman angled cannula, as shown in FIG. 7. Generally, for the purposes ofproviding access to medical needle 20 along a plane orthogonal to a lineof percutaneous entry and parallel to a plane of an entry site, medicalneedle 20 is angled. This configuration is consistent with a Huberneedle. Other angled medical needles may be protected by the apparatusin accordance with the present disclosure. The distal portion of medicalneedle 20 has an inferiorly disposed sharpened end 60. The proximalportion includes a superiorly disposed abrupt end 80 and a mediallydisposed bend 70 is formed therebetween.

[0067] Needle hub assembly 30, as shown in FIG. 7A, includes anappendage 100 by which needle hub assembly 30 is grasped and displaced.Needle hub assembly 30 also includes a hub body section 110, into whichend 80 of medical needle 20 is securely affixed, and a slider part 120.Slider part 120 engages elongated part 140 to facilitate extension ofshield assembly 140, as will be discussed below.

[0068] Referring to FIGS. 7B and 8, shield assembly 40 includes ahorizontally disposed stabilizer part or finger part 130 and anelongated part 140. A needle guide 150 is disposed at a distal end ofelongated part 140. Stabilizer part 130 may include a plurality of holes152, which reduce the amount of material required to constructstabilizer part 130 and provide for line-of-sight visualization ofmedical needle 20, especially during needle insertion procedures and forevaporation and air circulation. A medially disposed hole 154 instabilizer part 130 provides a through pathway for medical needle 20 andadditional opportunity to see a needle insertion target. Stabilizer part130 may be formed to have a sufficiently large accessible surface 160 topermit digital pressure to be applied in the direction of an insertionsite. Such pressure is normally applied to a needle insertion site tocounter anticipated frictional release forces when extracting medicalneedle 20 therefrom. Further, during extension of elongated part 140,pressure applied to stabilizer part 130 fixes the position of stabilizerpart 130 relative to movement of elongated part 140 towards the extendedposition.

[0069] A pair of juxtaposed triangularly shaped struts 162 and 164,which extend outward from surface 160, may be medially disposed abouthole 154. Struts 162 and 164 are configured to have a minimum top widthsuch that a hinge connection may be made (e.g., by injection molding)with elongated part 140. Struts 162 and 164 may be hingedly connected toelongated part 140 via a pair of hinges 166 and 168, respectively.Hinges 166 and 168 are living hinges integrally molded in shieldassembly 40, although elongated part 140 may be made separate fromstabilizer part 130, within the scope of the disclosure and joined byother kinds of hinges, such as pin hinges, etc. Elongated part 140 mayhave a pair of juxtaposed outwardly extending wings 170 and 172 to whichhinges 166 and 168 are respectively joined. It is contemplated thatstruts 162,164 may have other configurations, such as, rectangular,parabolic, etc., and of varying dimension, according to the particularrequirements of a medical application and in conformity with theprinciples of the present disclosure.

[0070] Referring to FIGS. 7B and 8, right-side disposed members 173, ofelongated part 140, may include an outwardly disposed, elongated siderail 174 and a medially disposed elongated side rail 176. Defining anaxis along the length of elongated rails 174 and 176 to be a y axis ofan x, y, z coordinate system, rails 174 and 176 are mutually displacedalong an x axis to cooperatively form a guide channel 178. Elongatedrails 174 and 176 may be mutually displaced, as shown in FIG. 8, along az axis to provide an offset which facilitates injection moldmanufacture, as one skilled in the fabrication arts.

[0071] Distally disposed relative to hinge 168, rail 174 may comprise alatching arm 180 which is angularly displaced into guide channel 178. Aswill be disclosed in detail hereafter, latching arm 180 may be disposedto catch slider part 120 (FIG. 7A) to function as a latch and affixmedical needle 20 within a safety shield provided by shield assembly 40.Other latches are also contemplated which would so affix shield assembly40 as a safety shield may be used within the scope of the presentdisclosure. Guide channel 178 may be closed distal to latching arm 180by a joining segment 182. Segment 182 may be disposed to limit travel ofslider part 120 in guide channel 178.

[0072] A bridging part 184 may be distally disposed relative to latchingarm 180 and hinge 168. Bridging part 184 may be provided as astrengthening member and may not be required if other parts of shieldassembly 40 are sufficiently rigid to perform as an adequate safetyshield. Bridging part 184 may join right-side disposed members 173 toleft-side disposed members 185 of elongated part 140, as shown in FIG.8.

[0073] Similar to right-side disposed members 173, left-side disposedmembers 185 of elongated part 140 may comprise an outwardly disposed,elongated side rail 194 and a medially disposed elongated side rail 196,as shown in FIG. 6. Elongated rails 194 and 196 define they axis andrails 194 and 196 may be mutually displaced along the x axis tocooperatively form a guide channel 198. Elongated rails 194 and 196 maybe mutually displaced along the z axis to provide an offset whichfacilitates injection mold manufacture.

[0074] Distally disposed relative to hinge 166, rail 194 may comprise alatching arm 200 which is angularly displaced into guide channel 198.Similar to latching arm 180, latching arm 200 may be disposed to catch aslider part 120′ to affix medical needle 20 within a safety shieldprovided by shield assembly 40. Guide channel 198 may be closed, distalto latching arm 200, by a joining segment 202. Segment 202 may bedisposed to limit travel of slider part 120′ in guide channel 198. Thisconfiguration facilitates affixing shield assembly 40 as a safetyshield.

[0075] Bridging part 184 may be distally disposed relative to latchingarm 200 and hinge 166, as discussed above. Left-side members 185 provideredundancy and, therefore, a lower likelihood of failure of a safetyshield. It is contemplated that only one or a plurality of sliderpart/guide channel combinations be employed.

[0076] Referring to FIG. 8, a second bridging part 204, mediallydisposed between needle guide part 150 and hole 154 may also providestructural support for elongated part 140 between left-side andright-side members, 173 and 185, respectively. Bridging part 204 maycomprise a slot 205 which is aligned with guide part 150 to permittravel of medical needle 20 therethrough. Additional structural supportfor elongated part 140 may be provided by an inferiorly disposedbridging part 206, as shown in FIG. 6.

[0077] Needle guide 150 may be affixed to stabilizer part 130 in linewith slot 205 and hole 154, as shown in FIG. 8. Needle guide 150 mayinclude a medially disposed through bore hole 210 and an exteriorsurface 212. The diameter of bore hole 210 should be large enough forfacile passage of medical needle 20 therethrough, but sufficiently smallto assure a firm contact between guide part 150 and medical needle 20when elongated part 140 is vertically disposed relative to stabilizerpart 130 and latched, as, by example, slider part 120 being engaged bylatching arm 180. Needle guide 150 may include a tubular or cylindricalsection that advantageously facilitates extension of shield assembly 140to the extended position. The tubular or cylindrical section of needleguide 150, among other components of safety shield apparatus 10,controls motion relative to medical needle 20 during extraction from aninsertion site preventing undesired “rebounding” or jerking of medicalneedle 20.

[0078] Referring to FIG. 7C, tubing 50 provides a communicating fluidpathway between medical needle 20 and fluid holding devices which areremote from a patient to whom medical needle 20 is affixed. As shown inFIG. 3, tubing 50 may be directly affixed to medical needle 20. Tubing50 may be so affixed by adhesive, press fit or other ways of securingtubing to needles, which are well known in the medical devicemanufacturing art.

[0079] Medical needle 20 may be securely affixed to hub body section 110which includes a bore hole 220 sized to receive tubing 50, as shown inFIG. 3. Bore hole 220 may end abruptly at a ledge 224 which surrounds asmaller hole defined by a constraining rim 226. In this way, securelyaffixing medical needle 20 into tubing 50 which resides in bore hole220, assures rigid containment of both tubing 50 and medical needle 20within body section 110. Tubing 50 may be securely attached to bodysection 110 within bore hole 220 by adhesive, insert molding, press fit,etc.

[0080] Appendage 100 includes a digital (manipulable) interface whichmay be facilely gripped by a clinicians fingers. Appendage 100 may havea winged interface 230, as shown in FIGS. 1-5. Winged interface 230 mayinclude two winged parts, 232 and 234. Winged parts 232 and 234 may behinged or flexible and horizontally disposed, as shown in FIGS. 2 and 3to provide a low silhouette until safety shield apparatus 10 is to beremoved from an insertion site. This configuration advantageouslypermits less obstruction for tape down and other site preparation overextended periods of use.

[0081] As shown in FIG. 1, winged part 232 (and winged part 234) may bearticulated to a more vertical orientation when extracting medicalneedle 20. Winged interface 230 permits extraction forces to be applieddirectly above and in-line with a longitudinal axis insertion line ofmedical needle 20. To aid in gripping and transferring extraction forcesto winged interface 230, winged parts 232, 234 may include corrugation,texturing or other process to increase surface friction.

[0082] The manufacture of safety shield apparatus 10 parts may beaccomplished by injection molding of hub assembly 30 and shield assembly40, both of which may be injection molded using synthetic resinousmaterial, such as polypropylene. Medical tubing 50 may be selected frommedical tubing currently commercially available. To assemble safetyshield apparatus 10, slider parts may be displaced into slideablecontainment in an associated guide channel, such as slider part 120being displaced into guide channel 178. In FIG. 6, a tubing channel 240may be formed by separation of juxtaposed rails 176 and 196. Tubing 50may be displaced through channel 240 and into bore hole 50, aspreviously disclosed. End 80 of medical needle 20 is displaced intotubing 50 and securely affixed thereat.

[0083] As seen in FIGS. 1-3, safety shield apparatus 10 may be properlysterilized and otherwise prepared for storage, shipment and use. Safetyshield apparatus 10 may be properly affixed, via stabilizer part 130,and inserted with a subject (not shown) for a port access medicalprocedure, such as, for example, one or a plurality of infusion and/orcollection of fluid procedures. Upon completion of the medicalprocedure(s), force may be applied to surface 160 of stabilizer part(finger pad) 130 while retracting forces are applied to winged parts 232and 234. Thus, stabilizer part 130 remains in a fixed position, relativeto movement of shield assembly 40 to the extended position. Needle guide150 may slidably support medical needle 20 to facilitate extension ofshield assembly 40 and prevent undesired “rebound” or jerking motionduring extraction.

[0084] Medical needle 20 is thereby extracted from an insertion site. Asmedical needle 20 is extracted, hub assembly 30 is displaced away fromsurface 160 displacing slider parts 120 and 120′ along respective guidechannels 178 and 198. Elongated part 140 is thereby articulated untilsharpened tip 60 of medical needle 20 is displaced into protectiveshielding of shield assembly 40 and slider parts 120 and 120′ areunreleasably, respectively engaged by latching arms 180 and 200. Asshown in FIGS. 4A and 5, sharpened tip 60 of medical needle 20 is fullyenclosed by shield assembly 140.

[0085] To assure shielding of sharpened tip 60, medical needle 20 may becaptured and held within a rigid, triangular frame formed having sidesmade of portions of medical needle 20, hub body section 110, elongatedpart 140 and guide part 150. As shown in FIG. 4, a triangle 250 isformed by dashed lines which represent legs 252, 254 and 256 of triangle250. For clarity, each internal angle of triangle 250 is referenced asan angle between adjacent legs (e.g., the angle associated with bend 70of medical needle 20 and slider part 120 is referenced by angle252/254.)

[0086] In an alternate embodiment, when elongated part 140 isarticulated away from stabilizer part 130 and slider parts 120 and 120′are respectively affixed by latching arms 180 and 200 (FIG. 5),elongated part 140 firmly engages exterior surface 212 of guide part 150(FIG. 4A). As medical needle 20 is restrained within bore hole 210, anendpoint 258 of each leg 252 and 256 and angle 252/256 is defined (FIG.4). An angle 252/254 is defined by construction of needle bend 70 andhub body section 110. All internal angles of triangle 250 arepredetermined. With all internal angles known, and at least one sidedetermined, the size and structure of triangle 150 is fixed. A commonendpoint 260 for legs 256 and 254 is defined to be at slider part 120. Acommon endpoint 262 for legs 252 and 254 is at bend 70. Thus, an attemptto force hub assembly 30 toward stabilizer part 130 and thereby to drivesharpened end 60 outwardly through hole 154 is defeated, and medicalneedle 20 is safely contained within shield assembly 40.

[0087] Within the scope of the present disclosure, a straight medicalneedle may be used in place of medical needle 20, see for example, theembodiment shown in FIG. 34 and discussed hereafter. In such a case, ahub assembly which is firmly and securely affixed to the straight needleand which permits fluid communication with medical tubing would have aslider part (similar to slider part 120) transversely displaced relativeto the straight medical needle to engage a guide channel (similar toguide channel 178).

[0088] Referring to FIGS. 9 and 10, another embodiment of a safetyshield apparatus 10′, similar to the apparatus and methods of use ofsafety shield apparatus 10 described above, is shown. Safety shieldapparatus 10′ may have a winged interface 230′ used to apply extractiveforce to pull medical needle 20 of safety shield apparatus 10′ from aninsertion site. As shown in FIG. 9, safety shield apparatus 10′ has apair of wings 270 and 272 affixed to a hub assembly 30′. Wingedinterface 230′ may have holes disposed in wings 270 and 272 to form pullrings 274 and 276, respectively. Such rings are provided to facilitateapplying pull force in direct line with medical needle 20 when wingedinterface 230′ is upwardly disposed as shown in FIG. 10.

[0089] Referring to FIGS. 11 and 12, another embodiment of a safetyshield apparatus 10″, similar to the apparatus and methods of use ofsafety shield apparatus 10 described above, is shown. Safety shieldapparatus 10″ includes a medical needle 20, a needle hub assembly 30, ashield assembly 40′ and a section of medical tubing 50.

[0090] As shown in FIG. 11, safety shield apparatus 10″ may have astabilizer part or finger pad 130′, which may be made from a transparentmaterial, although translucent or opaque material may be used within thescope of the present disclosure. Further, stabilizer part 130′ may alsobe flexible allowing it to be folded about other parts of safety shieldapparatus 10″ during medical needle 20 insertion. Stabilizer part 130′may be a thin sheet having sufficient tensile strength to allow shieldassembly 40′ to be displaced to sheath and protect medical needle 20without tearing, similar to stabilizer part 130, discussed above. Oneadvantage of configuring stabilizer part 130′ as a thin sheet is topermit tactile feedback about the insertion site, while withdrawingmedical needle 20. In a Huber needle application, medical needle 20penetrates a septum of an implanted port, tactile feedback andstabilization of the port itself during medical needle 20 extraction isdesirable.

[0091] In FIG. 11, stabilizer part 130′ may be folded about safetyshield apparatus 10″ to permit visual access to medical needle 20. InFIG. 12, stabilizer part 130′ may be broadly spread to permit manualaccess and application of force while extracting medical needle 20 to becaptured within the shield provided by shield assembly 40′.

[0092] Stabilizer part 130′ may include an anchor part 130″ both havinga centrally disposed hole 154 for passage of medical needle 20. Anchorpart 130″ may have a sufficient diameter to provide a base for struts162 and 164 and a secure attachment to stabilizer part 130′. Stabilizerpart 130′ may be mechanically affixed, injection molded, adhered, etc.,to anchor part 130″. Stabilizer part 130″ may be fabricated frommaterials such as polyolefin, polyurethane film, woven or non-wovenfabrics, synthetic foam, etc.

[0093] Referring to FIGS. 13-19, another embodiment in accordance withthe present disclosure is shown. As shown in FIG. 13, a safety shieldapparatus 310, similar to the apparatus and methods of use of safetyshield apparatus 10 described above, includes a medical needle 20, aneedle hub assembly 330, a shield assembly 340 and a section of medicaltubing 50.

[0094] A needle hub assembly 330 may include an appendage 100′ by whichhub assembly 330 can be grasped and displaced, and a hub body section110′ into which end 80 of medical needle 20 is securely affixed. Hubassembly 330 may include a pin hinge 360 whereby hub assembly 330 ishingeably affixed to shield assembly 340. Living hinges are alsocontemplated. Referring to FIGS. 17 and 18, shield assembly 340 mayinclude a first articulating part 400 having an end 402 which is joinedto hub assembly 320 via pin hinge 360. Articulating part 400 may behingeably associated with a second articulating part 410, at a first end412 through a pin hinge 414. Living hinges are also contemplated.

[0095] Articulating part 400 may be symmetrical about a longitudinalaxis having a pair of side parts 416 and 418, as shown in FIG. 18.Articulating part 400 may also be single sided. A bridging member 420may join and support separation of side part 416 and 418 and therebydefines a rectangular space 422 between parts 416 and 418.

[0096] Articulating part 410 may be shorter than part 400 and includesside members 424 and 426, as seen in FIG. 18. Parts 400,410 may be ofvarying relative dimension. A bridging member 430 joins and supportsseparation of side parts 424 and 426. Side parts 424 and 426 areseparated such that articulating part 410 may be foldably disposedwithin space 422, permitting shield 340 to be compacted into a lowsilhouette, as shown in FIG. 13. Disposed in articulating part 410,between bridging member 430 and bridging member 420 of articulating part400, may be an opening 432. Opening 432 permits a clip 434 to be moldedinto articulating part 410, as shown in FIG. 17. Clip 434 may have astem section 436 coupled to a latch 437 which is displaced beyondmedical needle 20 when shield assembly 340 is extended, as shown inFIGS. 15-17. Latch 437 catches medical needle 20 to affix shieldassembly 340 in a protective position about medical needle 20 andsharpened tip 60, as disclosed in detail hereafter. Other clips may beused within the scope of the present disclosure.

[0097] At a second end 438, part 410 may be hingeably affixed to alinear guide 440. Linear guide 440 may include a medially disposedthrough hole 444 which is slidably disposed about medical needle 20(FIGS. 14 and 17) and acts as a guide for shield assembly 340 asarticulating parts 400 and 410 are unfolded to provide a protectivesheath for medical needle 20 and sharpened tip 60. As shown in FIG. 18,distal from hinge 442, linear guide 440 may include a flattened plate446, similar to stabilizer part 130, discussed above.

[0098] A thin resilient disk 450 may include an accessible surface 452and, thereby, provides for tactilely sensing disposition of a targetimplant and for distributing tactile forces across a broader surfacearea than that which is accessible through finger contact alone. Bymaking disk 450 of transparent or material through which medical needle20 may be seen, an insertion site may be more easily viewed during apercutaneous, entry procedure. Also, a resilient disk 450 may be foldedabout hub assembly 320 to provide an unobstructed view during the entryprocedure.

[0099] As one who is skilled in injection mold manufacture and partsmolding understands, hub assembly 320 and shield assembly 340 may bemolded from a single injection molded part, as such may be preferred toreduce the cost of manufacture of safety shield apparatus 310. Medicalgrade polypropylene may be used to mold assemblies 320 and 340.Assemblies 320 and 340 are generally symmetrical about an axial midlinedefined by a shaft 460 of medical needle 20 (FIG. 14).

[0100] As shown in FIG. 14, hub assembly 320 may comprise a through hole470 which is narrowed toward disposition of bend 70 of medical needle 20and is enlarged toward an attachment site 472 between medical needle 20and tubing 50. An abrupt edge 474 retards the length of insertion oftubing 50 such that when tubing 50 is adhesively affixed to medicalneedle 20 about end 80, a combination of such adhesion and bend 70securely affixes medical needle 20 in needle hub assembly 320. Otherneedle to tubing joints are possible within the scope of the presentdisclosure. With shield assembly 340 hingeably affixed to hub assembly320 as shown in FIG. 18, safety shield apparatus 310 may be assembled bydisplacing medical needle 20 through space 422 in articulating part 400,through hole 444 in guide 440 of articulating part 410 and through apair of medially disposed holes 476 and 478 of plate 446 and-disk 450,respectively, as shown in FIG. 14.

[0101] In an alternate embodiment, to assure shielding of sharpened tip60, medical needle 20 may be captured and held within a rigid structure,a triangular frame is formed having sides made up of portions of medicalneedle 20, hub body section 110′, articulating part 400 and that portionof articulating part 410 which includes latching structure associatedwith clip 434. As shown in FIG. 17, a triangle 480 is formed by dashedlines which represent legs 482, 484 and 486 of triangle 480. Leg 484 isdefined by end points at bend 70 and pin hinge 360. Leg 486 is disposedparallel to radius of angle of rotation of articulating part 400 and isdefined by an end point at pin hinge 360 and intersection with shaft 460of needle 20. Leg 482 is defined by an end point at bend 70 and point ofintersection with line 486. For clarity, each internal angle of triangle480 is referenced as an included angle between adjacent legs (e.g., theinternal angle at bend 70 between shaft 460 of medical needle 20 and leg484 toward pin hinge 360 is referenced by angle 482/484).

[0102] When shield assembly 340 is unfolded and part 400 is articulatedaway from stabilizer parts (plate 446 and disk 450) and part 410 isrotated into alignment with shaft 460 as shown in FIGS. 15-17, clip 434catches and affixes part 410 relative to needle 20. So affixed, triangle480 is defined. Thus, triangle 480 establishes a rigid structureassuring protective cover for needle 20 and tip 60 which is thenprotected by shaft 460 surrounding guide 440. Angle 482/484 is fixed bystructure associated with bend 70 and pin hinge 360. Angle 484/486 isdetermined by clip 434 being disposed to latch shaft 460. Angle 482/486is defined because the other two angles of triangle 480 are so defined.Thus, an attempt to force hub assembly 320 toward stabilizer parts 446and 450 and thereby to drive sharpened end 60 outwardly through holes476 and 478 is defeated, and medical needle 20 is safely containedwithin shield assembly 340. Shield assembly 340 may be constructed suchthat angle 482/486 is zero when clip 434 is affixed to shaft 460.

[0103] Referring to FIGS. 19-30, an embodiment of a safety shieldapparatus 744 is shown including a port access needle 746 including ashield 750 of hingedly connected segments 612′ and 614′ for protectingdistal end 747 of needle 746 after use in a medical procedure. Needle746 may be oriented in two axes such that a distal needle portion 746Ais oriented at an axis 90 degrees relative to an axis defined by aproximal needle portion 746B. It is contemplated that distal needleportion 746A and proximal needle portion 746B may be oriented at variousangular displacements. As shown in FIGS. 19-29, segments 612′ and 614′may be configured for a low profile such that the segments may be foldedinto each other in a pre-use state as a result of either segment havingsmaller dimensions than the other.

[0104]FIGS. 19 and 20 show safety shield apparatus 744 in a retractedposition, while FIGS. 21 and 22 show the extended and protected positionwith shield 750 attached to needle 746 by means of a needle latch 754shown in FIGS. 22, 26 and 27. Needle latch 754 has an arcuate outersurface 754A and a radial edge 754B. A deformable interior cavity 754Cof latch 754 corresponds to outer surface 754A. Upon actuation of shield750, needle 746 engages and travels along outer surface 754A untilneedle 754 becomes disposed over radial edge 754B. Outer surface 754Aelastically deforms to facilitate movement of needle 746 thereover andextension of shield 750. Shield 750 is manipulated until the fullyextended position is reached. Radial edge 754B prevents movement ofneedle 746 and consequently shield 750 to the retracted position,thereby locking shield 750 in the fully extended position. Movement ofneedle 746 is prevented due to the compressive forces created in outersurface 754A and tensile forces in 754B via engagement of needle 746 andradial edge 754B.

[0105] As shown in FIGS. 26 and 27, a rib 770 may be utilized forpositioning the needle 746 with respect to needle latch 754. Needle 746may be latched to shield 750 by various other means as set forth herein.For example, in an alternate embodiment, as shown in FIGS. 31 and 32, aneedle latch 946 formed with shield 750. Needle latch 946 has a surface950 on which needle 746 rests to lock shield 750 in the extendedposition. Surfaces 948 and 952 retain needle 746 with surface 950 in thelocked and extended position. In operation, as shield 750 is manipulatedto the fully extended position, needle 746 engages latch 946 and travelsover latch arm 954, which biases permitting needle 746 to enter latch946 and come to rest with surface 950. Latch arm 954 biases back, and incooperation with surfaces 948, 952 retains needle 746, andcorrespondingly, shield 750 in the extended and locked position.

[0106] Shield 750 may further comprise a planar contact surface, suchas, for example, disc 752 attached to linear bearing 638′, which may bepermanently attached or releasably attached. Linear bearing 638′ mayalso be monolithically formed with disc 752. Disc 752 may furtherinclude foldable portions (not shown), such as by living hinges, forpackaging purposes. Texturing may also be added to the top surface ofdisc 752 to enhance gripping of disc 752, as shown in FIGS. 24A and 25A.Disc 752 may also be hingedly attached to distal segment 614′ throughhinge 782, thereby leaving linear bearing 638′ free from communicationwith the disc 752. Linear bearing 638′ remains connected to distalsegment 14′ through living hinge 78.

[0107] Referring to the embodiment shown in FIG. 28, an additionallockout feature may be added for securing safety shield apparatus 744 inthe lockout mode. For the embodiment shown in FIG. 28, the lockout isaccomplished by engagement of latches 776 disposed on distal segment614′ to flanges 778 disposed on linear bearing 638′.

[0108] Shield 750 is passively activated upon withdrawal of the needle746 from a patient, wherein wings 748 may be used to facilitateinsertion and withdrawal of the safety shield apparatus 744. One methodof withdrawing needle 746 from a patient includes the steps of holdingdisc 752 against a patient while pulling wings 748 away from thesubject. Once the needle latch 754 engages the needle 746, the safetyshield apparatus 744 may be removed. It is contemplated that disc 752 isadherently attached to the subject. Disc 752 may also be releasable fromlinear bearing 638′.

[0109] The hinges connecting segments 612′ and 614′ and linear bearing638′ may be flexible living hinges 678, pinned hinges, or equivalentsthereof that provide for hinged connections of segments 612′ and 614′and the linear bearing 638′ (see, e.g., FIG. 26). Moreover, the numberof hingedly connected segments depends upon needle 746 length and devicelength required to extend shield 744 beyond distal end 747 of needle746. Embodiments of the safety shield apparatus 744 may, therefore,include two or more segments.

[0110] As shown in the embodiment illustrated in FIG. 19, needle 746 hasa proximal end and a distal end 747 with the proximal end of needle 746affixed in a hub 758. Wings 748 may be affixed to the needle hub. In theembodiment shown in FIG. 25, safety shield apparatus 744 is assembled byinserting hub 758 into collar 760. Flared surfaces 762 may be includedon hub 758 to engage collar 760. The needle hub may also be configuredto attach an extension set tubing 736. In an alternate embodiment, asshown in FIG. 33, needle hub 758 and wings 748 include an opening 748A.Opening 748A permits linear bearing 638′ (see, e.g., FIG. 26) to extendfurther into needle hub 758 and wings 748, and form a friction fittherewith, such that shield 750 can be maintained in the retractedposition, as shown. This configuration advantageously provides greaterstability and increased coverage of needle 746.

[0111] Referring to FIGS. 23 and 24, an embodiment of safety shieldapparatus 744 is shown further comprising a pad 756, which may be addedunderneath disc 752 for patient comfort and as a spacer between apatient's skin and disc 752. Pad 756 may be comprised of a foam materialsuch as a closed-cell foam, polyurethane open-cell foam, or anequivalent crushed or densified, felted material. Pad 756 may be anabsorbent, breathable material that may also be capable of wickingmoisture. Pad 756 may also be impregnated with an antimicrobial agent,such as chlorhexidine or equivalent material. Pad 756 may also becomprised of a foam material with a thin film coating on either sideincluding, but not limited to, polyolefin, breathable polyurethane, orother equivalent materials. The thin film coating may also beperforated.

[0112] Pad 756 may be separately packaged in a sterile container for useas a replacement pad for an existing dressing. Pad 756 may also be usedas a dressing, which may replace or supplement a gauze dressing.

[0113] Pad 756 may have a friction fit capability for attachment toneedle 746, with a possible slit 764 included for ease of attachment tosafety shield apparatus 744. Pad 756 may also be permanently attached tosafety shield apparatus 744. A notch 780 may be added to slit 764 toassist in guiding the pad 756 into the proper position on the needle746. Holes 766 may be added to the pad 756 for purposes such as aidingin visibility and increasing air flow to the pad 756. Similar holes maybe added to the disc 752 for the same purposes.

[0114] Referring to the embodiment shown in FIG. 29, safety shieldapparatus 744 may be retained in the retracted position by a flange 772disposed on proximal segment 612′ engaging notches 774 in a flange 778disposed on linear bearing 638′. Alternative embodiments may include aflange disposed on the hub 758 or distal segment 674′ with correspondingnotches located on an alternate segment or hub 758.

[0115] Referring to FIG. 34, another alternate embodiment of a safetyshield apparatus 810, in accordance with the principles of the presentdisclosure, similar to the apparatus and methods of use of safety shieldapparatus 10, 10″, 310 and 744 described above, is shown. Safety shieldapparatus 810 includes a port access medical needle 820, a needle hubassembly 830, a shield assembly 840 of hingedly connected segments 842and 844 for protecting a distal portion 860 of needle 820, and a sectionof medical tubing 50. Medical needle 820 has a linear shaft extendingalong a longitudinal axis c and a distal portion 860 and a proximalportion 880. Proximal portion 880 is mounted to needle hub assembly 830.The channel of fluid flow 852 in hub assembly 830 may be angled suchthat a relatively straight needle 820 may be utilized, rather than anangled needle as heretofore shown.

[0116]FIG. 34 shows safety shield apparatus 810 in the extended andprotected position with shield 840 attached to needle 820 by means of aneedle latch 846, similar to the needle latches described above.

[0117] Shield assembly 840 may further comprise a planar contactsurface, such as, for example, disc 848 attached to linear bearing 850,which may be permanently attached or releasably attached. Linear bearing850 may also be monolithically formed with disc 848. Shield assembly 840is extensible between a retracted position and an extended position,similar to the embodiments described above, via fixed positioning ofdisc 848.

[0118] In another embodiment, the hub, may be configured to include aluer fitting for attachment to various needle devices such as a syringeor IV set.

[0119] It will be understood that various modifications may be made tothe embodiments disclosed herein. Therefore, the above descriptionshould not be construed as limiting, but merely as exemplification ofthe various embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A safety shield apparatus comprising: a needleshield having a planar contact surface; a pad having a first surfacemountable to the planar contact surface and a second surface configuredfor engagement with a body surface.
 2. The safety shield apparatusaccording to claim 1 wherein said pad is made from a foam material. 3.The safety shield apparatus according to claim 1 wherein said pad ismade from a felted material.
 4. The safety shield apparatus according toclaim 1 wherein said pad is made from a breathable material.
 5. Thesafety shield apparatus according to claim 1 wherein said pad is madefrom a material configured for wicking moisture.
 6. The safety shieldapparatus according to claim 1 wherein said pad is impregnated with anantimicrobial agent.
 7. The safety shield apparatus according to claim 1wherein at least one of said surfaces includes a thin film coatingdisposed thereon.
 8. The safety shield apparatus according to claim 7wherein said thin film coating is perforated.
 9. The safety shieldapparatus according to claim 1 wherein said pad comprises: a planarshape having a thickness defining a peripheral surface connecting saidfirst and second surfaces; and a slit extending from said peripheralsurface to about a center of said pad.
 10. The safety shield apparatusaccording to claim 9 wherein said pad further comprises a notch leadingfrom said peripheral surface into said slit.
 11. The safety shieldapparatus according to claim 9 wherein said planar shape comprises adisk.
 12. The safety shield apparatus according to claim 9 furthercomprising a needle operatively disposed with said needle shield whereinsaid pad is retained to said needle safety device by a friction fitbetween said pad and said needle.
 13. The safety shield apparatusaccording to claim 12 wherein said friction fit is provided between saidslit and said needle.
 14. The safety shield apparatus according to claim1 wherein said pad is permanently attached to said planar contactsurface.
 15. The safety shield apparatus according to claim 1 whereinsaid pad further includes at least one through-hole.
 16. The safetyshield apparatus according to claim 1 further comprising means forattachment of said pad to a safety shield apparatus.
 17. The safetyshield apparatus according to claim 1 wherein said needle shieldcomprises a Huber safety needle shield.
 18. A safety shield apparatuscomprising: a needle having a distal portion and a proximal portion; anextensible needle shield having a distal end planar contact surface anda proximal end attached to said proximal portion of said needle; and apad adapted for spacing between said planar contact surface and asubject's skin; said pad including a first surface adapted for disposalagainst said planar contact surface; a second surface adapted to fordisposal against said subject's skin; a planar shape having a thicknessdefining a peripheral surface connecting said first and second surfaces;and a slit extending from said peripheral surface to about a center ofsaid pad; wherein said pad is retained to said safety shield apparatusby a friction fit between said pad and said needle.
 19. The safetyshield apparatus according to claim 18 wherein said pad furthercomprises: a notch leading from said peripheral surface into said slit;and at least one through hole providing fluid communication between saidfirst and second surfaces.
 20. A safety shield apparatus comprising: aneedle having a distal portion and a proximal portion; an extensibleneedle shield having a distal end planar contact surface and a proximalend and attached to said proximal portion of said needle; and a padadapted for spacing between a planar contact surface of a safety needledevice and a subject's skin,  wherein said pad comprises: a firstsurface adapted for disposal against said planar contact surface; asecond surface adapted to for disposal against said subject's skin; aplanar shape having a thickness defining a peripheral surface connectingsaid first and second surfaces; and wherein said pad is permanentlyattached to said needle safety device.